This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have postmarketing requirement(s) for ongoing clinical trial(s) to verify clinical benefit.
Similar Posts
Green Lumber Holding, LLC Issues Consumer Alert on Counterfeit Products Following FDA Findings
Costa Mesa, California August 28, 2025 – Green Lumber Holding, LLC (“Green Lumber”) is alerting consumers that counterfeit products misrepresented as genuine Green Lumber have been identified and may pose health risks.Pediatric Exclusivity Granted
Approved active drugs with sponsors to which FDA has granted exclusivity for pediatric studies under Section 505A of the Federal Food, Drug, and Cosmetic Act (FD&C Act)Central Admixture Pharmacy Services Inc. Allentown, PA. 483 issued 09/05/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 09/05/2025
Short Title (70 char) Central Admixture Pharmacy Services Inc. Allentown, PA. 483 issued 09/05/2025
FEI Number 3009590582
Firm Name Central Admixture Pharmacy Services Inc
Record Type 483
State PA
EstStokes Healthcare Inc. dba Epicur Pharma. Mount Laurel, NJ. 483 issued 05/23/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 05/23/2025
Short Title (70 char) Stokes Healthcare Inc. dba Epicur Pharma. Mount Laurel, NJ. 483 issued 05/23/2025
FEI Number 3002815949
Firm Name Stokes Healthcare Inc. dba Epicur Pharma
Record Type 483
State NMedWatch Forms for FDA Safety Reporting
Safety reporting portal for health professionals, patients, consumers and industry. Find pdf fillable forms in English and Spanish and a link to report safety concerns to the FDA online.FDA-TRACK: Biosimilar User Fee Act Procedural Response Goals Summary
FDA-TRACK: Biosimilar User Fee Act Procedural Response Goals Summary